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Designation: F 86 01

Standard Practice for

Surface Preparation and Marking of Metallic Surgical


Implants1
This standard is issued under the fixed designation F 86; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (e) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.

should be removed to minimize localized rust formation and


superficial blemishes.
3.3 The various chemical and electrochemical surface treatments specified in this standard are intended to remove
objectionable surface contaminants and to restore maximum
corrosion resistance to the passive oxide film.
3.4 The need for an additional implant surface treatment
such as secondary passivation in nitric acid should be evaluated
for localized implant surfaces that have electrochemical or
laser product markings created after the final surface treatment.

1. Scope
1.1 This practice provides a description of surface characteristics, methods of surface preparation, and methods of
marking for metallic surgical implants. Marking nomenclature
is not specified in this practice. Surface requirements and
marking methods included in the implant specification shall
take precedence over requirements listed in this practice, where
appropriate.
1.2 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

4. Description of Acceptable Surface Characteristics


4.1 Metallic implants, when inspected in accordance with
this practice, shall be free of surface imperfections such as
toolmarks, nicks, scratches, cracks, cavities, burrs, and other
defects that would impair the serviceability of the device. The
surfaces shall be cleaned to minimize the presence of foreign
material.
4.2 Specific finish requirements such as texture, surface
roughness, or additional surface treatments shall be included in
the implant production specification.
4.3 The implants shall be given a final surface treatment
according to Section 7.

2. Referenced Documents
2.1 ASTM Standards:
A 380 Practice for Cleaning and Descaling Stainless Steel
Parts, Equipment, and Systems2
A 967 Specification for Chemical Passivation Treatments
for Stainless Steel Parts2
B 600 Guide for Descaling and Cleaning Titanium and
Titanium Alloy Surfaces3
F 983 Practice for Permanent Marking of Orthopaedic Implant Components4

5. Cleaning
5.1 The surface of the implants shall be cleaned to minimize
foreign material.
5.2 The cleaning operations used shall relate to the following as appropriate:
5.2.1 A method such as organic solvent degreasing for the
removal of oils, greases, and other loose surface contaminants.

3. Significance and Use


3.1 The surface treatments documented in this specification
are intended to improve the corrosion resistance of metallic
surgical implants manufactured from iron, cobalt, titanium, and
tantalum base materials.
3.2 Iron particles, ceramic media, and other foreign particles
may become smeared over or imbedded into the surface of
implants during processing operations such as forming, machining, tumbling, bead blasting, and so forth. These particles

NOTE 1Anhydrous methanol and other solvents known to cause


environmentally assisted cracking of titanium and its alloys should be
avoided.

5.2.2 A method such as one of the following for the removal


of adherent foreign material, if necessary.
5.2.2.1 Hot alkaline cleaner used as recommended.
5.2.2.2 Alkaline cleaner applied electrochemically as recommended.

This practice is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Jan. 10, 2001. Published March 2001. Originally
published as F 86 84. Last previous edition F 86 00.
2
Annual Book of ASTM Standards, Vol. 01.03.
3
Annual Book of ASTM Standards, Vol. 02.04.
4
Annual Book of ASTM Standards, Vol. 13.01.

NOTE 2Avoid cathodic cleaning of metals known to be susceptible to


hydrogen contamination and anodic cleaning of metals known to be

Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.

F 86
susceptible to pitting. In addition, testing should be considered to confirm
that acidic cleaning will not affect the mechanical properties of alloys
susceptible to hydrogen contamination effects.

marking method and procedure, the marking may be applied


before or after the final surface treatment. (See 7.6).

5.2.2.3 Ultrasonically agitated cleaning agent.


5.2.3 An acidic cleaning process may be used. For titanium,
titanium alloys, and tantalum, some possible cleaning processes may be found in Practice B 600.

7. Final Surface Treatment


7.1 Implants shall be given a final surface treatment before
they are packaged.
7.2 Final surface treatments are as follows:
7.2.1 Immerse in 20 to 45 volume % nitric acid (specific
gravity 1.1197 to 1.285) at room temperature for a minimum of
30 min. For an accelerated process, a 20 to 25 % acid solution,
heated at 120 to 140F (40 to 60C), may be used for a
minimum of 20 min. (See Specification A 967 and Practice
A 380).
This treatment provides passivation by surface oxidation and
is able to dissolve certain foreign material that might be present
from previous operations; it is therefore particularly recommended when no other treatments take place that would
remove such foreign material.
7.2.2 Use a neutralizing procedure for product designs in
which acidic liquid could be trapped.
7.2.3 A thorough water rinsing process and a drying process
are essential.
7.3 Alternatively, for stainless steel and cobalt alloys, a final
electropolishing procedure can provide passive surface conditions and cleansing from certain foreign material (see Specification A 967).
7.4 For titanium base materials, electrochemical anodizing
processes can provide similar passivating and cleaning effects
as the electrochemical polishing procedures have. Alternative
oxidation treatments can render passive surfaces as well.
7.5 If alternative surface treatments for implants are used,
these treatments should be specified in the production procedure documentation.
7.6 If marking of implants is performed after the final
surface treatment, it must be evaluated whether a secondary
passivation treatment is necessary or not.

NOTE 3Before an acidic cleaning, degreasing shall be considered


where appropriate to make the acidic cleaning effective in a uniform
manner.

5.2.3.1 If acidic cleaning methods are used, this shall be


stated in the implant production specification.
5.3 A neutralizing treatment shall be carried out where
appropriate.
5.4 An adequate rinsing operation shall be carried out.
5.5 An adequate drying cycle shall follow.
6. Product Marking
6.1 Markings are applied to the implant surfaces to provide
traceability if the size and configuration of the implant are
sufficient for such markings. To minimize potential adverse
effects, it is necessary to use an appropriate marking procedure
and technique and to select a suitable location for the marking
of the implant.
6.1.1 Details on marking are found in Practice F 983.
6.2 Identify or label metallic implants in a manner that will
minimize potential impairment of the mechanical properties or
corrosion resistance and will not elicit adverse tissue response.
6.3 Locate the marking or labeling on the implant at a point
of low stress in such a manner as not to intersect the edges of
drilled holes, countersinks, or edges of implants. Indicate the
location of the marking on the manufacturing drawing of the
implant.
6.4 The marking nomenclature shall be documented.
6.5 Some methods of marking are as follows:
6.5.1 Mechanical imprinting of round-bottom and roundedge characters,
6.5.2 Chemical etching using an anodic electrolytic procedure,
6.5.3 Marking with a round rotating burr under low-contact
pressure,
6.5.4 Casting of markings into the surface using round-edge
and round-bottom characters,
6.5.5 Marking with vibrator-type contact,
6.5.6 Electro-pencil marking, and
6.5.7 Marking with laser beam.
6.6 Depending on the implant, its material, and the type of

8. Inspection
8.1 The surfaces of the finished implants, at least representative samples of a production lot, shall be inspected using
visual examination with the unaided eye (but corrected where
necessary). Other surface inspection methods may be used in
addition.
9. Keywords
9.1 alkaline cleaner; cleaning; electropolishing; final inspection; marking; metal implants; passivation; surface treatment

F 86
APPENDIX
(Nonmandatory Information)
X1. RATIONALE

X1.1 The surface treatment and marking of implants can


influence the following important qualities: local tissue response, bonding or lack of bonding to tissues as indicated by
the application, and fatigue strength of implants.

surface characteristics to inhibit local undesirable tissue response are therefore required.
X1.3 The fatigue strength of implants is affected by the
topography of the surfaces, residual stresses, and structure. The
fatigue strength of a component may be determined experimentally. Therefore, to evaluate or test the fatigue strength of
finished implants, they should have surface structures, residual
stresses, surface treatments, and other characteristics that are
representative of the manufacturing process by which the
implant is produced.

X1.2 Local tissue response of metallic implants is affected


by corrosion that, in turn, may be affected by embedded foreign
particles and other factors. Foreign material on the surfaces as
a result of manufacturing operations may jeopardize the
compatibility even in the absence of corrosion or may affect
contacting implant components. Specifications and control of

SUMMARY OF CHANGES
(3) The passivation treatment in 7.2.1 has been adjusted to
agree with the latest version of A 967.
(4) The information specified in 7.3 was previously changed in
the F 86-00 revision to omit the nitric acid rinse required after
electropolishing since it is recognized that electropolishing is a
satisfactory passivation treatment.
(5) A Significance and Use section has been added to this
standard in accordance with form and style guidelines for
ASTM Practices and Guides.
(6) The statement This standard has been approved for use by
agencies of the Department of Defense has been deleted.

(1) The discontinued standards (F 55, F 56, F 642, F 643,


F 644, and F 666) were removed from the Referenced Documents section during the F 86-00 revision. The balance of the
metallic implant material standards previously included in the
Referenced Documents section have been deleted since they
were not mentioned in the text and it is considered impractical
to revise this document every time a new metallic implant
material standard is published. Paragraph 3.1 documents that
this standard is applicable for metallic surgical implants
manufactured from iron, cobalt, titanium, and tantalum base
materials.
(2) The different sections of the standard have been rearranged
in a logical order, and the section on Final Surface Treatment
has been slightly extended in consideration of the increased use
of titanium materials.

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